Whey hydrolysate formula reduced crying time in infantile colic
QUESTION: Is whey hydrolysate formula effective in the treatment of infantile colic in formula fed infants in a primary care setting?
Randomised (allocation concealed), blinded (research nurses and parents), placebo controlled trial with follow up immediately after 1 week of intervention.
Community based, well baby clinics in 6 regions of the Netherlands.
43 healthy, thriving, formula fed (≥1 formula feeding per d) infants <6 months old who cried for >3 hours/day on ≥3 days/week (average >4.5 h/d). Exclusion criteria included participation in a previous trial of hypoallergenic feeding, anaphylactic reactions to cows' milk, and non-Dutch speaking parents. 5 infants (12%) did not complete the trial but were included in the analysis. For the 38 who did complete the trial, 53% were boys and the mean weight was 4.7 kg.
After a 1 week qualification period, 23 infants were allocated to whey hydrolysate formula (Nutrilon Pepti) and 20 to standard cows' milk formula (Nutrilon Premium) for a 1 week intervention period. Every infant was provided with 2 cans of formula powder, each can con-taining 400 g. To make the taste, smell, and appearance of the 2 formulas similar, a quarter of the powder in each can of standard formula was substituted with hydrolysate powder.
Main outcome measures
The primary outcome was difference in duration of crying (min/d) between the qualification week and intervention week. The secondary outcome was proportion of infants no …